Regulatory Affairs Manager to SHI Pharma/Swedish Herbal Medicine Institute

SHI Pharma/ The Swedish Herbal Medicine Institute was founded in 1969. The business includes the development and manufacture of effective products with well-documented effects; among others Kan Jang, Chisan, and Arctic Root. All production – from plant raw material to finished product – takes place in Vallberga, 3 miles south of Halmstad, where the company conducts its business. The plant is approved for the production of medicines and food supplements according to both GMP (Good Manufacturing Practice) and HACCP

The company was recently acquired by GOBIA Enterprises, a Swedish family-owned investment company within Life Science, and we are now investing together in an international expansion of Kan Jang as Traditional Plant-based Medicine

Do you want to be involved in internationalizing SHI Pharma and developing one of Sweden's leading brands in Herbal Medicines?

The position
We are looking for direct recruitment, a Regulatory Affairs Manager (RA. The position involves many exciting challenges and varied work with everything from product registration, responsible contact with authorities and ensuring that the work is carried out in accordance with current regulations. The position as RA is newly established, fulltime and the location is in Vallberga (south of Halmstad) and the working hours are daytime, Monday to Friday with the possibility of some hybrid work.

Main duties and responsibilities:

Responsible for product registrations of herbal medicines in Europe
Regulatory contact person for authorities and customers
Regulatory knowledge to ensure compliance with requirements in Sweden and Europe
Be involved in interntal inspections and external audits
Review and apporove SOPs, specifications and other quality related documents

Personal Profile:

Analytical skills and driven
Result orientated
Open to challenges and to learn
Precise and reliable
Excellent communication and problem solving skills
Able to work independently and in team

Requirements for the position:

University degree in Pharmacy, Medical, Biology or Natural Sciences
4-5 years documented regulatory experience in pharmaceutical industry
Previous experience of working with authorities
Experience of working with GMP
Fluent in Swedish and English, both spoken and written.
Driving license “B”

It is advantageous if you have experience from a production environment and understand the importance of this operational work this type of service requires.

Application
If you are interested in this position, please apply immediately. Any questions about the service are answered by Processbemanning AB, tel. 042-210299. Your application is treated confidentially, and we will apply an ongoing recruitment process, which is why we ask you to apply immediately. The application is made via the link below.

Does this sound interesting?
Then you are welcome to submit your application immediately. We apply an ongoing recruitment process and encourage you to apply immediately. Your application will be treated confidentially.

Please read more about us at processbemanning.se where you will also find our other vacant positions!

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